medical Class II Updated 2021-08-25

OPTI Medical Systems, Inc recalls OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99

Recalled Product

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004


Hazard / Issue

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

Issued by

FDA

Distribution: Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Lot/Code Info: a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
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